Bill Text: CA AB1437 | 2013-2014 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Medically important antimicrobials: livestock and poultry.
Spectrum: Partisan Bill (Democrat 5-0)
Status: (Introduced - Dead) 2014-04-30 - In committee: Set, first hearing. Hearing canceled at the request of author. [AB1437 Detail]
Download: California-2013-AB1437-Introduced.html
Bill Title: Medically important antimicrobials: livestock and poultry.
Spectrum: Partisan Bill (Democrat 5-0)
Status: (Introduced - Dead) 2014-04-30 - In committee: Set, first hearing. Hearing canceled at the request of author. [AB1437 Detail]
Download: California-2013-AB1437-Introduced.html
BILL NUMBER: AB 1437 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Mullin
JANUARY 6, 2014
An act to amend Sections 14200, 14203, 14289, and 14381 of, to add
Sections 14203.5, 14207.3, 14207.5, 14207.7, 14220, 14297, and 14366
to, and to add Article 5.5 (commencing with Section 14335) and
Article 5.6 (commencing with Section 14340) to Chapter 4 of Division
7 of, the Food and Agriculture Code, relating to livestock drugs.
LEGISLATIVE COUNSEL'S DIGEST
AB 1437, as introduced, Mullin. Medically important
antimicrobials: nontherapeutic use.
Existing law requires the manufacturer of a livestock drug,
including a restricted drug, as defined, to register with the
Director of Food and Agriculture and requires the director to refuse
to register the drug if he or she makes specified findings. Under
existing law it is unlawful, among other things, to use or administer
any registered livestock drug, except in accordance with the label
instructions, as specified, and makes an initial violation of these
provisions subject to an infraction and, for subsequent violations, a
misdemeanor.
This bill, as of January 1, 2017, would redefine "restricted drug"
to also include a livestock drug that is recognized by either the
Center for Disease Control and Prevention or the World Health
Organization to increase the prevalence of antibiotic-resistant
bacteria, as specified. The bill would prohibit registration of a
restricted drug if the director finds that the restricted drug poses
a risk to public health through the increased prevalence of
antibiotic-resistant bacteria. The bill would also authorize the
director to revoke the registration of a medically important
antimicrobial, as defined, for use in livestock if he or she finds
that the drug threatens the public health by increasing the
prevalence of antibiotic-resistant bacteria.
The bill would prohibit the administration of a medically
important antimicrobial to a food-producing animal for nonroutine
disease control unless certain conditions are met. By prohibiting the
administration of a medically important antimicrobial, this bill
would create a crime, thereby imposing a state-mandated local
program. The bill would also require a livestock producer that does
administer a medically important antimicrobial to a food-producing
animal to annually report specified information to the director
relating to the administration of the medically important
antimicrobial and would make the failure to make that report an
infraction subject to specified penalties. The bill would require the
department post this information on an Internet Web site.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature find and declare all of the following:
(a) In 1977, the United States Food and Drug Administration (FDA)
concluded that feeding livestock low doses of antibiotics that are
used in human disease treatment could promote the development of
antibiotic-resistance in bacteria. The FDA, however, did not act in
response to these findings, despite laws requiring the agency to do
so.
(b) The FDA has promulgated voluntary regulations on the
nontherapeutic use of antibiotics, however these guidelines are
unlikely to significantly reduce the nontherapeutic use of
antibiotics in livestock.
(c) Not only do antibiotic-resistant bacteria affect the health of
our society, but they also have a monetary impact. In 1998, the
National Academy of Sciences noted that antibiotic-resistant bacteria
generate a minimum of four to five billion dollars in costs to
United States society and individuals every year.
(d) In April 1999, the United States Government Accountability
Office conducted a study concluding that three strains of
microorganisms that cause foodborne illnesses or disease in humans
are resistant to antibiotics and are linked to the use of antibiotics
in animals. These microorganisms are salmonella, Campylobacter, and
E. Coli.
(e) In 1999, 2011, and 2006, the United States Department of
Agriculture's Animal and Plant Health Inspection Service conducted
large-scale, voluntary surveys that revealed all of the following:
(1) Eighty-four percent of grower and finisher swine farms, 83
percent of cattle feedlots, and 84 percent of sheep farms administer
antimicrobials in feed or water for either health or growth promotion
reasons.
(2) Many of the antimicrobials that were identified were identical
or closely related to drugs used in human medicine, including
tetracyclines, macrolides, bacitracin, penicillins, and sulfonamides.
(3) These drugs are used in people to treat serious diseases, such
as pneumonia, scarlet fever, rheumatic fever, sexually transmitted
infections, and skin infections; pandemics such as malaria and
plague; and bioterrorism agents such as anthrax.
(f) Overuse or misuse of antibiotics contributes to the spread of
antibiotic resistance, whether in human medicine or in agriculture.
(g) In June 2002, the peer-reviewed journal, "Clinical Infectious
Diseases," published a report based on a two-year review, by experts
in human and veterinary medicine, public health, microbiology,
biostatistics, and risk analysis, of more than 500 scientific studies
on the human health impacts of antimicrobial use in agriculture. The
report recommended that antimicrobial agents should not be used in
agriculture in the absence of disease and should be limited to
therapy for diseased individual animals or prophylaxis when disease
is documented in a herd or flock.
(h) In a March 2003 report, the National Academy of Sciences
stated that a decrease in antimicrobial use in human medicine alone
will have little effect on the rise in antibiotic-resistant bacteria
and that substantial efforts must be made to decrease the
inappropriate overuse of antimicrobials in animals and agriculture.
(i) In 2010, the peer-reviewed journal, "Molecular Cell,"
published a study demonstrating that a low-dosage use of antibiotics
causes a dramatic increase in genetic mutation, raising new concerns
about the agricultural practice of using low-dosage antibiotics in
order to stimulate growth promotion and routinely prevent disease in
unhealthy conditions.
(j) In 2010, the Danish Veterinary and Food Administration
testified that the Danish ban of the nontherapeutic use of
antibiotics in food animal production resulted in a marked reduction
in antimicrobial resistance in multiple bacterial species, including
Campylobacter and Enterococci.
(k) In 2011, the FDA found that in 2010:
(1) Thirteen million five hundred thousand kilograms of
antibacterial drugs were sold for use on food animals in the United
States.
(2) Three million three hundred thousand kilograms of
antibacterial drugs were used for human health.
(3) Eighty percent of antibacterial drugs disseminated in the
United States were sold for use on food-producing animals, rather
than being used for human health.
(l) In 2011, a review of all scientific studies on antimicrobial
use in farm animals, published in Clinical Microbiology Reviews,
found the following:
(1) The use of antibiotics in food-producing animals leads to the
development of reservoirs of antibiotic resistance.
(2) A ban on nontherapeutic antibiotic use in food-producing
animals would preserve the use of antibiotics for medicine.
(3) A Danish ban on nontherapeutic antibiotics in food-producing
animals resulted in little change in animal morbidity and mortality,
and only a modest increase in production cost.
(m) The FDA's National Antimicrobial Resistance Monitoring System
routinely finds that retail meat products are contaminated with
bacteria that are resistant to antibiotics that are important to
human medicine.
(n) According to the American Academy of Pediatrics, " t]he
largest nonhuman use of antimicrobial agents is in food-producing
animal production, and most of this is in healthy animals to increase
growth or prevent diseases. Evidence now exists that these uses of
antimicrobial agents in food-producing animals have a direct negative
impact on human health and multiple impacts on the selection and
dissemination of resistance genes in animals and the environment.
Children are at increased risk of acquiring many of these infections
with resistant bacteria and are at great risk of severe complications
if they become infected."
(o) Many scientific studies confirm that the nontherapeutic use of
antibiotics in food-producing animals contributes to the development
of antibiotic-resistant bacterial infections in people.
SEC. 2. Section 14200 of the Food and Agricultural Code is amended
to read:
14200. (a) The Legislature hereby declares
that this chapter, which prescribes the distribution and use of
livestock drugs, is intended to assure that such
the drugs are available to livestock producers for their
use in protecting the health of the livestock population of the
state, and that such the use will in
turn benefit the general public by providing an abundant supply of
wholesome food and fiber.
It
(b) It is further declared that
nothing in this chapter is intended to prevent a livestock producer
from administering livestock drugs safely and effectively when
such the use is in accordance with the
labeling directions for the drug used and when the use protects
public health .
SEC. 3. Section 14203 of the Food and Agricultural Code is amended
to read:
14203. (a) "Restricted drug" means
any livestock either of the following:
(1) A livestock drug which is
sold in such a form that it might be
administered to humans and a person and,
if so administered administered,
would be dangerous to the health of such humans or any
livestock the person.
(2) A livestock drug
which that if improperly
administered administered, as defined in Section
14203.5, to livestock , is dangerous to the health
of such the livestock or to
humans p ersons who consume products
from such the livestock.
Restricted
(3) A livestock drug that is recognized by either the federal
Centers for Disease Control and Prevention or the World Health
Organization to increase the prevalence of antibiotic-resistant
bacteria.
(b) Restricted drugs include all
of the following:
(a)
(1) Arsenic compounds and preparations.
(b)
(2) Diethylstilbestrol and other substances which have
a hormonelike action.
(c)
(3) Sulfanilamide or substitute sulfanilamides.
(d)
(4) Antibiotic preparations.
(e)
(5) A drug from an antimicrobial class that is listed as "highly
important," "critically important," or "important" by the World
Health Organization's "Critically Important Antimicrobial for Human
Medicine," as updated by the World Health Organization, or its
successor publication, unless the drug is used for therapeutic use,
as defined in Section 14220.
Such other
(6) Other drugs and their
preparations which that the director
determines are hazardous to the health of livestock or the public
safety.
SEC. 4. Section 14203.5 is added to the Food and Agricultural
Code, to read:
14203.5. "Improperly administered" means either of the following:
(a) Administration of a medically important antimicrobial to a
food-producing animal through either feed or water, or for purposes
of poultry hatcheries through any means, for purposes other than
therapeutic use, such as growth promotion, feed efficiency, weight
gain, disease prevention, or nonroutine disease control.
(b) A repeated or regular pattern of administration of a medically
important antimicrobial in food-producing animals for purposes other
than therapeutic use or nonroutine disease control.
SEC. 5. Section 14207.3 is added to the Food and Agricultural
Code, to read:
14207.3. "Medically important antimicrobial" means a drug that is
both of the following:
(a) Intended for use in food-producing animals.
(b) Composed wholly or partly of either of the following:
(1) Any kind of penicillin, tetracycline, macrolide, lincosamide,
streptogramin, aminoglycoside, sulfonamide, or cephalosporin.
(2) A drug from an antimicrobial class that is listed as either
"highly important," "critically important," or "important" by the
World Health Organization's "Critically Important Antimicrobial for
Human Medicine," as updated by the World Health Organization, or its
successor publication.
SEC. 6. Section 14207.5 is added to the Food and Agricultural
Code, to read:
14207.5. "Noncustomary situation" means a situation that does not
include normal or standard practices and conditions on the premises
that facilitate the transmission of disease.
SEC. 7. Section 14207.7 is added to the Food and Agricultural
Code, to read:
14207.7. "Nonroutine disease control" means the use of
antimicrobials in the feed or water of a food-producing animal that
is not sick, and where a particular disease or infection is, or is
likely to be, present on the premises because of a specific,
noncustomary situation.
SEC. 8. Section 14220 is added to the Food and Agricultural Code,
to read:
14220. "Therapeutic use," with respect to a medically important
antimicrobial, means the use of the antimicrobial for the specific
purpose of treating an animal with a documented disease or infection.
Therapeutic use does not include the continued use of the
antimicrobial in the animal after the disease or infection has been
resolved.
SEC. 9. Section 14289 of the Food and Agricultural Code is amended
to read:
14289. If the livestock drug is a restricted drug, the director
shall also refuse registration if he or she finds that the
instructions for use do not contain adequate and satisfactory
directions as to the methods of handling, caring for, holding, or
otherwise managing the livestock to which the drug is administered so
as to eliminate any danger to the health of any person who might
consume food products which that are
derived from such that livestock
or if he or she finds that the restricted drug poses a risk to public
health by increasing the prevalence of antibiotic-resistant bacteria
.
SEC. 10. Section 14297 is added to the Food and Agricultural Code,
to read:
14297. The director may revoke the registration of a medically
important antimicrobial for use in livestock if he or she finds that
the drug as used poses a risk to the public health by increasing the
prevalence of antibiotic-resistant bacteria.
SEC. 11. Article 5.5 (commencing with Section 14335) is added to
Chapter 4 of Division 7 of the Food and Agricultural Code, to read:
Article 5.5. Use of Medically Important Antimicrobials
14335. (a) A person who administers or causes to be administered
a medically important antimicrobial to a food-producing animal shall
have a valid veterinarian-client-patient relationship with a
veterinarian to ensure that the medically important antimicrobial is
used in a manner that is consistent with professionally accepted best
practices.
(b) For purposes of this section, "veterinarian-client-patient
relationship" means a relationship in which all of the following are
met:
(1) The veterinarian has assumed the responsibility for making
medical judgments regarding the health of the animal-patient, and the
client has agreed to follow the veterinarian's instructions.
(2) The veterinarian has sufficient knowledge of the
animal-patient to initiate at least a general or preliminary
diagnosis of the medical condition of the animal-patient.
(3) The veterinarian is readily available for follow-up
evaluation, or has arranged for veterinary emergency coverage, and
continuing care and treatment.
(4) The veterinarian provides oversight of treatment, compliance,
and outcome of the administration of the medically important
antimicrobial.
(5) Animal-patient records are maintained.
(c) For purposes of this section, "sufficient knowledge" means the
veterinarian is personally acquainted with the keeping and care of
the animal-patient by virtue of either of the following:
(1) A timely examination of the animal-patient by the
veterinarian.
(2) Medically appropriate and timely visits by the veterinarian to
the premises where the animal-patient is kept.
14336. (a) If a livestock producer administers or causes to be
administered a medically important antimicrobial to a food-producing
animal, the producer, or the contracted entity, shall annually report
to the director the following information on a schedule and in a
format specified by the director:
(1) The total number of food-producing animals given a medically
important antimicrobial in their feed.
(2) The type of medically important antimicrobial administered.
(3) The total amount of each medically important antimicrobial
used.
(4) The target food-producing animal species that were
administered the medically important antimicrobial.
(5) The length of time over which the medically important
antimicrobial was intended to be provided to the food-producing
animals and the dose of the active medically important antimicrobial
ingredient the food-producing animals were intended to receive.
(6) The purpose for administering the medically important
antimicrobial to a food-producing animal. The purpose shall be
categorized in a manner determined by the director and shall include,
at a minimum, the following categories:
(A) Growth promotion.
(B) Disease prevention.
(C) Disease control.
(D) Disease treatment.
(7) The type of disease or infection to be treated by the
medically important antimicrobial, if applicable.
(8) The name of the processor, as defined in Section 20019, where
the livestock product will be processed.
(b) On or before December 31, 2017, the department shall develop
and make operational a consumer-friendly, publicly accessible
Internet Web site that creates a database of the information
collected pursuant to this section. The database shall be searchable
and able to accommodate a wide range of users, including users with
limited technical and scientific literacy. The Internet Web site
shall be designed to be easily navigable and to enable users to
compare and contrast livestock producers and the reported usage of
medically important antimicrobials.
SEC. 12. Article 5.6 (commencing with Section 14340) is added to
Chapter 4 of Division 7 of the Food and Agricultural Code, to read:
Article 5.6. Nontherapeutic Use of Medically Important
Antimicrobials
14340. This article shall apply to the nontherapeutic use in a
food-producing animal of a drug that is a medically important
antimicrobial and is either of the following:
(a) A registered drug.
(b) A drug exempted under Article 3 (commencing with Section
14261).
14341. The registration or exemption of a drug subject to this
article shall be ineffective on and after January 1, 2017, unless the
director makes a final written determination that there is, with
reasonable certainty, no harm to human health due to the development
of antimicrobial resistance that is attributable in whole or in part
to the nontherapeutic use of the drug, based on one of the following:
(a) The holder of the registration or exemption has demonstrated
this fact.
(b) A risk analysis of the drug, taking into consideration other
relevant information, conducted by the director.
SEC. 13. Section 14366 is added to the Food and Agricultural Code,
to read:
14366. It is unlawful to administer, including through means of
feed, a medically important antimicrobial to a food-producing animal
for nonroutine disease control, unless either of the following apply:
(a) The director determines, with reasonable certainty, that there
is no harm to human health due to the development of
antibiotic-resistant bacteria that is attributable in whole or in
part to the use of the medically important antimicrobial and the use
does not threaten public health.
(b) All of the following conditions are met:
(1) There is a significant risk that a disease or infection that
is present on, or is likely to be present on, the premises will be
transmitted to the food-producing animal.
(2) The administration of the medically important antimicrobial to
the food-producing animal is necessary to prevent or reduce the risk
of transmission of the disease or infection.
(3) The medically important antimicrobial is administered to the
food-producing animal for the shortest duration possible to prevent
or reduce the risk of transmission of the disease or infection.
(4) The medically important antimicrobial is administered to the
fewest food-producing animals possible in order to prevent or reduce
the risk of transmission of the disease or infection.
SEC. 14. Section 14381 of the Food and Agricultural Code is
amended to read:
14381. A (a) Except
as provided for in subdivision (b), a violation of this
chapter or of any regulation which that
is adopted by the director pursuant to this chapter is an infraction
punishable by a fine of not more than five hundred dollars ($500)
for the first violation. A second or subsequent violation of this
chapter is a misdemeanor punishable by a fine of not less than one
hundred dollars ($100) and not more than one thousand dollars
($1,000).
(b) A violation of the reporting requirement in Section 14336 or
of any regulation that is adopted by the director pursuant to that
section is an infraction punishable by a fine of one hundred dollars
($100) for the first violation. A second or subsequent violation is
an infraction punishable by a fine of not less than two hundred
dollars ($200) and not more than one thousand dollars ($1,000).
SEC. 15. This act shall become operative on January 1, 2017.
SEC. 16. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.
